QTX3544 in Patients with Advanced Solid Tumors with KRAS G12V Mutations

Quanta Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Combination Product: Cetuximab; Drug: QTX3544

Study type: Interventional

Funder types: Industry

Identifiers

NCT06715124

QTX3544-201

Details and patient eligibility

About

Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.

Enrollment: 237 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
• Part 1: Advanced solid tumors with at least one prior systemic therapy.
• Evaluable and measurable disease per RECIST v1.1.
• Part 2 and 3: Measurable disease per RECIST v1.1.

Exclusion criteria

• Active brain metastasis or carcinomatous meningitis
• Significant cardiovascular disease
• Active infection requiring intravenous (IV) antibiotics
• Prior treatment with a KRAS inhibitor

Other protocol-defined Inclusion/Exclusion Criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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237 participants in 4 patient groups

Part 1a: QTX3544 monotherapy dose escalation

Experimental group

Description:

QTX3544 will be administered at protocol defined dose based on cohort assignment

Treatment:

Drug: QTX3544

Part 1b: QTX3544 dose escalation in combination with cetuximab

Experimental group

Description:

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Treatment:

Drug: QTX3544

Combination Product: Cetuximab

Part 2: QTX3544 monotherapy dose expansion

Experimental group

Description:

QTX3544 will be administered at protocol defined dose based on cohort assignment

Treatment:

Drug: QTX3544

Part 3: QTX3544 dose expansion in combination with cetuximab

Experimental group

Description:

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Treatment:

Drug: QTX3544

Combination Product: Cetuximab